12 patients in Pakistan go blind after cancer treatment injection: What does the Ministry of Health say?

Authorities in Pakistan have announced a temporary suspension of a cancer treatment drug (Avastin) distributed by Swiss pharmaceutical company Roche for investigation after 12 patients became blind after being injected with the drug.

Regarding this information, the Drug Administration of Vietnam ( Ministry of Health ) has just announced that on September 27, the Representative Office of F. Hoffmann La Roche Ltd. has sent an official dispatch reporting updated information on the investigation related to the above-mentioned drug Avastin .

In Vietnam, Avastin has 4 valid circulation registration certificates, specifically:

4 valid registration certificates for Avastin

According to the Drug Administration of Vietnam, Avastin is granted a circulation registration certificate in Vietnam with the following treatment indications: Metastatic colorectal cancer, advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, glioblastoma/malignant glioma (stage IV), epithelial ovarian, fallopian tube and primary peritoneal cancer.

In addition to the general warnings, the FDA-approved package insert also warns that "not to be used for intravitreal injection. Specifically: The drug may cause visual disturbances. Individual cases and clusters of serious ocular adverse events have been reported following intravitreal injection, an unapproved route of administration, with Avastin mixtures from vials intended for intravenous infusion in cancer patients.

Avastin is used in the treatment of cancer.

These reactions include: Intraocular infection, endophthalmitis, such as sterile endophthalmitis, uveitis and vitritis, retinal banding, retinal pigment epithelial tear, increased intraocular pressure, intraocular hemorrhage such as vitreous hemorrhage or retinal hemorrhage, and conjunctival hemorrhage. Some of these events have resulted in varying degrees of vision loss, including permanent blindness.

A representative of the Drug Administration of Vietnam said that as of September 27, the agency has not received any reports reflecting unwanted effects of Avastin related to patients losing vision after using Avastin.

According to the report of the Representative Office of F. Hoffmann La Roche Ltd. in the official dispatch No. RA/02/09/2023 reporting updated information on the investigation related to the drug Avastin sent to the Drug Administration Department, in Pakistan, about 12 patients lost their vision after using the injection drug provided by the illegal supplier Genius Pharmaceutical Service. According to this report, the drug was labeled "Inj. Avastin 1.25 mg/0.05 ml" causing the false perception that this was a Roche product.

Roche's Avastin is not approved for any ophthalmic use. Genius Pharmaceutical Service supplied/diluted/repackaged the 1.25 mg/0.5 ml dose under unsanitary and unapproved conditions.

N. Dung

Source: https://nld.com.vn/suc-khoe/12-benh-nhan-o-pakistan-bi-mu-sau-tiem-thuoc-dieu-tri-ung-thu-bo-y-te-noi-gi-20230927203357295.htm